Pharmaceutical Testing of India's People
Tarleton State University
This paper looks at the pharmaceutical medical trials and clinical drug testing on the people of India as the ethical perspective conducted from journals and articles provided along with a video that was shown to understand the perspective of what we were to analyze. The journals speak on the process of approval, laws that are in place to advocate for the people, and the overall plight of the subjects that sign up for the clinical trials. The World Health Organization (WHO) and the Drugs Controller of General India (DGCI) are the two main controlling factions in the process to monitor and ...view middle of the document...
The technology that is used to teach at the universities in India is top notch along with the ever present information for up and coming technology. English is commonly used by middle class residents but more often used by the educated residents. The country focuses on a staying as a globalized market with a free market economy stating that the government has little to no control over the basis of supply and demand. There are not heavy handed restrictions as to how buyers and sellers can interact. This has been an extremely welcoming environment for new drug companies to come in and set up facilities for medical and clinical trials. For the drug companies that are established in the country already, it is a profitable place to be and for new companies coming in, it is seen as a cash cow, so to say.
There are many concerns when it comes to the testing phases in India. Most of the people that sign up for these trials are very low to no income people with little education. These people are usually given a voucher for a small amount of money, 25 Rupee or about $0.41 or free care and medicine for signing up to do the medical tests. The problem that is happening is the lack of informed consent. The subjects are signing forms that give consent that are written in English language but many in this lower caste cannot read or understand English so they are unsure what exactly they are signing. The trials are typically not run by the company itself but by a sponsor or clinical research organization (CRO) that conducts the trials on behalf of the company and shares the results. Antani and Gokhale (n.d.) state that liabilities that arise due to breach in “informed consent” due to adverse reactions from drugs or negligence gives limited liabilities to the sponsor and it is not exactly clear who is responsible for compensating the subject for what happened. There is the sponsor, the investigator / institution, the clinical research organization, and the insurance involved that covers the physicians. Most of the people that enter into these trials are in no way able to pursue a company for legal recourse in case of something happening such as serious injury or death. In India, there are no laws or acts that monitor the use of drugs or trials in the country so people that are involved in the trials can openly be exploited with out protection. There is a federal law and regulations in place that are needed for approvals of drug trials by the Drugs Controller of General India and the approval process can take much longer than it does in the United States where drugs can be approved for clinical use in as short of a period as 30 days. There is the Clinical Trials Registry – India (CTRI) that was launched in July of 2007 which is Asia's first clinical trials registry but there has been a great deal of resistance to the enrollment into this program. Pandey (2013) says many challenges for setting up the CTRI is to get trials that are accepted by the DCGI as there...